The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

Tri-Service General Hospital (TSGH)69 enrolled

Overview

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

ESWTDEVICE

Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs).

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 20-80 year-old. 2. Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study. Exclusion Criteria: 1. Cancer 2. Coagulopathy 3. Pregnancy 4. Inflammation status 5. Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Outcomes

Primary Outcomes

Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.

Visual analog scale (VAS)

Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Secondary Outcomes

Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks

Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.

Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks

Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks

electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).

Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Data from ClinicalTrials.gov

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